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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 December 2001- 20 December 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
EC Number:
603-330-9
Cas Number:
129332-29-2
Molecular formula:
C28H34FNO4
IUPAC Name:
tert-Butyl rel-(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation.
Number of animals or in vitro replicates:
3 animals of one sex

Results and discussion

In vivo

Irritant / corrosive response data:
Irritation: Instillation of approximately 29mg of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48hours in all animals.

Corrosion: There was no evidence of ocular corrision.

Colouration: No staining of ocular tissues by the test substance was observed. Remnants of the test substance were present in the eyes of all animals on day 1. Green staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.

Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Instillation of approximately 29mg of the test substance into one eye of each of three rabbits resulted in irritation of the conjunctivae, which was seen as redness, chemosis and discharge. The irritation had completely resolved within 48hours in all animals

Remnants of the test substance were present in the eyes of all animals on day 1. Green staining of the fur on the heads and paws, caused by the test substance, was noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation. Non irritant.
Executive summary:

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation. Non irritant.